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A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer (NSCLC)

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Trial Information

A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures


Inclusion Criteria:



- Suspected or confirmed NSCLC (up to and including Stage II)

- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only
one lobe of the lung

- Performance status 0-1 (Eastern Cooperative Oncology Group classification)

- ASA score < 3

- No prior history of VATS or open lung surgery

- Willing to give consent and comply with study-related evaluation and treatment
schedule

Exclusion Criteria:

- Active bacterial infection or fungal infection;

- Systemic administration (intravenous or oral) of steroids (within 30 days prior to
study procedure)

- Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days
prior to the procedure

- Scheduled concurrent surgical procedure other than wedge resection or lobectomy
(central venous access - e.g. port placement, mediastinoscopy with lymph node
sampling, and VATS lymphadenectomy are allowed)

- Pregnancy

- Physical or psychological condition which would impair study participation;

- The patient is judged unsuitable for study participation by the Investigator for any
other reason; or

- Unable or unwilling to attend follow-up visits and examinations

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Occurrence of postoperative air leaks

Outcome Time Frame:

30 days

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

ESC-12-001

NCT ID:

NCT01843192

Start Date:

May 2013

Completion Date:

February 2014

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617